Section 802 of the Federal Agricultural Improvement and Reform Act of 1996 (The Farm Bill) authorized the creation of the National Agricultural Research, Extension, Education, and Economics Advisory Board. The Board is composed of 30 members, each representing a specific category related to farming or ranching, food production and processing, forestry research, crop and animal science, land-grant institutions, food retailing and marketing, rural economic development, and natural resource and consumer interest groups, among many others. The Board was first appointed in September 1996 and one-third of the 30 members were appointed for a 1, 2, and 3-year term, respectively.

As a result of the staggered appointments, the terms for 10 of the 30 members who represent 10 specific categories expired September 30, 2000. The Secretary of Agriculture made 3-year appointments for all 10 of the vacant categories. Appointees by category of the 10 new members are as follows: Representing Category A, National Farm Organization, Ronald R. Warfield, President of the Illinois Farm Bureau and Director of the American Farm Bureau Federation Executive Committee, was reappointed to a second term, Bloomington, Illinois; Category C. Food Animal Commodity Producer, Patricia Blum, beef rancher for 40 years and past President of South Dakota Beef Industry Council, Reliance, South Dakota; Category F. National Crop Commodity Organization, Marc S. Curtis, National and State President of the American Soybean Association, and farmer of rice, wheat, corn and soybeans, Leland, Mississippi; Category K. National Human Health Association, Judith S. Stern, Professor, Department of Internal Medicine, Division of Endocrinology, Clinical Nutrition and Vascular Medicine, University of California-Davis, California; Category P. Hispanic-Serving Institutions, John Cordova, President, South Mountain Community College, Maricopa Community College System, Phoenix, Arizona; Category Q. American Colleges of Veterinary Medicine, Oscar J. Fletcher, Dean, College of Veterinary Medicine and Professor of Farm Animal Health and Resource Management, North Carolina State University, Raleigh, North Carolina; Category S. Transportation of Food and Agricultural Products to Domestic and Foreign Markets, Emma Jean Cervantes, President of Cervantes Enterprises/Agribusiness, 35-year producer of chile peppers, cotton, alfalfa, vegetables, and pecans, La Mesa, New Mexico, previously appointed to a 1-year term and was reappointed to a full term; Category U. Food and Fiber Processors, John Rogers Farquharson, President of the International Food Safety Council, and Executive Emeritus, ARAMARK Corporation, Sewell, New Jersey, was reappointed to a second term; Category Z. Private Sector Organization involved in International Development, Shirley Dunlap Bowser, a diversified family farmer, engaged in the international dimension of agriculture, and Chair of W.K. Kellogg Foundation Board, Williamsport, Ohio; and Category CC. National Social Science Association, Jean Clarkson-Frisbie, Pratt County Extension Agent, Family and Consumer Sciences R-H and Youth, Cooperative Extension Service, Kansas State University, Pratt, Kansas. Appointees term will begin on October 1, 2000 and end September 30, 2003 (pending reauthorization of the Advisory Board beyond September 30, 2002). They will actively participate in their first meeting October 16-18, 2000, beginning at 9 a.m. October 16-17 and from 8 a.m.-12 noon October 18, at the Loew's L'Enfant Plaza Hotel, Ballroom A, Section A, 480 L'Enfant Plaza, SW., Washington, DC.

The Federal Government's intellectual property rights to this invention are assigned to the United States of America, as represented by the Secretary of Agriculture. It is in the public interest to so license this invention as the California Table Grape Commission has submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within ninety (90) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The Animal and Plant Health Inspection Service (APHIS) is considering amending the regulations on the importation of logs, lumber, and other unmanufactured wood articles to decrease the risk of solid wood packing material (e.g.,crates, dunnage, wooden spools, pallets, packing blocks) introducing exotic plant pests into the United States. The regulations in 7 CFR 319.40-1 through 319.40-11 (referred to below as the regulations) are intended to mitigate the plant pest risk presented by the importation of logs, lumber, and other unmanufactured wood articles, including solid wood packing material (SWPM). Introductions into the United States of exotic plant pests such as the pine shoot beetle and the Asian longhorned beetle have been linked to the importation of SWPM. These and other plant pests that could be carried by imported SWPM pose a serious threat to U.S. agriculture and to natural, cultivated, and urban forests.

On January 20, 1999, we published an advance notice of proposed rulemaking in theFederal Register(64 FR 3049-3052, Docket No. 98-057-1) to seek information and develop regulatory options on the general problem of plant pests in SWPM imported from any country. In the notice, we requested public comment on what actions would be most effective and appropriate to further reduce the risk of SWPM introducing exotic plant pests into the United States. We received 102 comments in response to the advance notice of proposed rulemaking.

To evaluate the risks associated with the importation of solid wood packing materials so that we can propose regulations that are consistent with those risks, we have prepared a draft pest risk assessment entitled “Pest Risk Assessment for the Importation of Solid Wood Packing Materials Into the United States.”

The specific objectives of this pest risk assessment are to:

• Describe the means by which pests could potentially be transported via SWPM (i.e.,pathways);

• Assess the potential for insect and pathogenic pests that may be transported with SWPM to enter the United States and become established; and

• Estimate the potential economic and environmental consequences these pests may have on forest and tree resources if they become established in the United States.

We are making this draft pest risk assessment available to the public for review and comment. In particular, we request feedback on the risk factors, methodology, and documentation used in the draft pest risk assessment. We will consider all comments that we receive by the date listed under the headingDATESat the beginning of this notice.

The draft pest risk assessment is available in our reading room (information on the location and hours of the reading room is listed under the headingADDRESSESat the beginning of this notice) or on the Internet athttp://www.aphis.usda.gov/ppq/pra/swpm.You may also request that a copy be mailed to you by registering athttp://www.aphis.usda.gov/ppq/pra/swpmor by contacting the person listed underFOR FURTHER INFORMATION CONTACT.If you request that a copy be mailed to you, please specify whether you desire a printed copy or a copy on compact disk.

In the matter ofHeartwood, Inc.v.U.S. Forest Service,Civ. No. 99-4255 (S.D. III. Sept. 15, 2000), the agency and plaintiff entered a settlement agreement that the agency would promulgate an interim final rule settling forth the notice, comment, and appeal procedures at 36 CFR part 215 for the following projects and activities:

(1) Projects involving the use of prescribed burning;

(2) Projects involving the creation or maintenance of wildlife openings;

(3) The designation of travel routes for off-highway vehicle (OHV)( use which is not conducted through the travel management planning process as part of the forest planning process;

(4) The construction of new OHV routes and facilities intended to support OHV use;

(5) The upgrading, widening, or modification of OHV routes to increase either the levels or types of use by OHVs (but not projects performed for the maintenance of existing routes);

(6) The issuance or reissuance of special use permits for OHV activities conducted on areas, trails, or roads that are not designated for such activities;

(7) Projects in which the cutting of trees for thinning or wildlife purposes occurs over an area greater than 5 contiguous acres;

(8) Gathering geophysical data using shorthole, vibroseis, or surface charge;

(9) Trenching to obtain evidence of mineralization;

(10) Clearing vegetation for sight paths from areas used for mineral, energy, or geophysical investigation or support facilities for such activities.

At the time of publication of the interim rule, the agency also will invite public comment for consideration in adopting a final rule.

Pending adoption of this interim rule, the agency agreed to give notice in theFederal Registerthat it would apply these notice, comment, and appeal procedures as of the effective date given in the notice.

A copy of the settlement agreement is available by writing the address listed earlier in this notice or by logging onto the “NEPA, NFMA and Appeals” page of the Forest Service homepage of the World Wide Web, the address for which is http://www.fs.fed.us/forum/nepa.

Section 343 of the Federal Agriculture Improvement and Reform Act of 1996 states that after enactment of the law, revisions made to NRCS state technical guides used to carry out highly erodible land and wetland 2 provisions of the law, shall be made available for public review and comment. For the next 30 days, the NRCS in Indiana will receive comments relative to the proposed changes. Following that period, a determination will be made by the NRCS in Indiana regarding disposition of those comments and a final determination of changes will be made.

The MPA lists all Census Bureau publications and data files for a 30-day period. It includes product ordering information and order forms. The MPA does not describe every data product, but usually does discuss one or two new ones in each issue.

The Census Bureau has decided to provide product information to the customer on a more timely basis. The new format will give the customer product information daily and allow the customer to purchase products immediately. We believe that changing to Internet access will not significantly affect the MPA's users. We will, however, address the needs of customers adversely affected by this change. Customers may request a paper copy that lists the Census Bureau's monthly releases by contacting the Customer Services Center at 301-457-4100.

The Office of Information Technologies in the U.S. Department of Commerce's International Trade Administration will conduct a public meeting on Wednesday, November 8, 2000 at 9 a.m., in room 3407, Herbert C. Hoover Building, 14th and Constitution Avenue NW., Washington, DC 20230. The purpose of the meeting is to introduce to U.S. information technology (IT) suppliers a new approach to IT market development overseas and explore ways to collaborate in this effort. There will be a demonstration and discussion of the IT Management Planning Tool, which was created to serve as a market stimulator for U.S. suppliers to generate demand for their IT products and services overseas. The IT Tool is a software application which helps management of businesses and government agencies assess their current IT usage and plan for future IT investments that can improve their operations. Because the IT Tool is intended for overseas audiences, the contents of the Tool will be localized and translated into several languages, including Spanish, Portuguese, Russian, Simplified Chinese, and Traditional Chinese. U.S. information technology suppliers and service providers interested in partnering with the U.S. Department of Commerce in this unique overseas market development effort should attend the meeting.

The meeting is open to the public, however, seating in room 3407 is limited and is available on a first come, first served basis. Those planning on attending the meeting should inform the Office of Information Technologies by October 27, 2000. To request further information concerning the meeting or to request a copy of the Information Technology Planning Tool, contact Tu-Trang Phan or Raymond Cho in the Office of Information Technologies at 202-482-0571 by phone, 202-482-3002 by fax, or by e-mail at ExportIT@ita.doc.gov.

On August 9, 2000, notice was published in theFederal Register(65 FR 48679) that the above-named applicant had submitted a request for a permit to take one species of marine mammals by Level B harassment during the course of commercial photographic activities in Piedras Blancas and Ano Nuevo, California. The requested permit has been issued, under the authority of §104(c)(6) of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361et seq.).

The Hague Conference on Private International Law is in the process of negotiating a new convention on jurisdiction and the recognition and enforcement of foreign judgments in civil and commercial matters. The draft convention would create jurisdictional rules governing international lawsuits and provide for recognition and enforcement of judgments by the courts of Member States. Member States would be required to recognize and enforce judgments covered by the Convention if the jurisdiction in the court rendering the judgment were founded on one of the bases of jurisdiction required by the Convention.

Discussions began in 1992, at the request of the United States. The impetus behind the request was to gain recognition and enforcement of U.S. judgments in other countries. While U.S. courts generally recognize and enforce judgments from other countries, U.S. judgments do not always receive the same treatment abroad.

The Hague Conference is planning a two-part Diplomatic Conference to finalize the draft convention. The first session would take place in June 2001, followed by a second session in late 2001 or early 2002.

The text of the proposed convention and other documents relating to the proposal are available via the Hague Conference's web site athttp://www.hcch.net/e/workprog/jdgm.html.

The draft convention would create three categories of jurisdiction: (1) required bases for jurisdiction (generally Articles 3-16); (2) prohibited bases for jurisdiction (Article 18); and (3) everything else not covered by (1) or (2) (Article 17).

Articles 3-16 set out jurisdictional rules for specific types of actions that the courts in Contracting States must provide, and from which any resulting judgment may gain the benefits of the recognition and enforcement provisions of the Convention.

Article 12 creates exclusive jurisdiction for certain actions that “have as their object” the registration, validity, nullity, and possibly revocation or infringement of patents, trademarks, or other similar rights required to be deposited or registered, in the courts of the country in which the deposit or registration has been applied for or has occurred. Copyrights are excluded from the exclusive jurisdiction rule; however, actions concerning copyrights could fall under the other non-exclusive required jurisdictional provisions.

Specifically, Article 12 provides:

The brackets identify potential language alternatives to be considered and discussed in detail during the Diplomatic Conference.

Article 4 provides that parties may enter into agreements designating a choice of court; however, such agreements shall be without effect if they conflict with the provisions of Article 12. In addition, Article 5, which confers jurisdiction on a court when the defendant proceeds on the merits without contesting jurisdiction, is subject to Article 12 as well.

Article 10 defines jurisdictional rules for tort actions. This provision would cover copyright infringement proceedings. It also could apply to patent and trademark infringement proceedings if the bracketed language in Article 12(4) is not approved. Article 10 provides for jurisdiction either in the State in which the act or omission causing injury occurred, or the State in which the injury arose so long as the injury in that State was reasonably foreseeable. Article 10(4) would limit available damages, where jurisdiction is founded on the place of injury, to the damage suffered in the place the suit is filed unless that is also the plaintiff's habitual residence.

Article 18 defines grounds of jurisdiction that are prohibited in Contracting States. Article 18(1) would place a general limitation on the exercise of jurisdiction based on the absence of a “substantial connection between that State and the dispute.” Article 18(2)(e) is of particular interest to U.S. litigants because it states that jurisdiction cannot be based solely on the fact that the defendant carries on commercial or other activities in that State, except where the dispute is directly related to those activities. This provision would prohibit the exercise of general “doing business” jurisdiction as currently recognized under U.S. law. Article 18(2) also would prohibit the exercise of “tag” jurisdiction in a court based on service upon the defendant in the State.

Everything that does not fall under either of these categories is included in the “gray area” as defined in Article 17. With some exceptions, countries can continue to act as they normally do under their national law; however, judgments resulting from actions covered by this provision will not get the benefits of recognition and enforcement under the Convention.

Chapter III provides rules for the recognition and enforcement of judgments based on a ground of jurisdiction provided for in Articles 3-16.

U.S. courts must have both personal jurisdiction over the parties and subject matter jurisdiction over the case before a court can act on a dispute.

Generally, in order to exercise personal jurisdiction over a nonresident defendant, district courts interpret the long-arm statute of the state in which they reside, as restricted by the limitations imposed by the due process clause of the U.S. Constitution.

Courts first apply the state long-arm statute, which defines what types of conduct would bring a nonresident defendant within the boundaries of the court's reach. Activities that can create jurisdiction under most long-arm statutes include transacting business, committing a tortious act within the forum, or committing a tortious act outside the forum that has an effect within the forum.

Once the court finds that the exercise of jurisdiction over the nonresident defendant is consistent with the relevant long-arm statute, the court then must determine whether the due process requirements are satisfied. The due process rule of the U.S. Constitution requires that a nonresident defendant have “minimum contacts with [the forum] such that the maintenance of the suit does not offend ‘traditional notions of fair play and substantial justice.’ ”International Shoe Co.v.Washington,326 U.S. 310, 316 (1945) (quotingMillikenv.Meyer,311 U.S. 457, 463 (1940)). In evaluating whether minimum contacts have been established in a given case, the courts ask if anonresident defendant, through his conduct and connection with the forum, “purposefully avails itself of the privilege of conducting activities within the forum state, thus invoking the benefits and protections of its laws.”Burger King Corp.v.Rudzewicz,471 U.S. 462, 475 (1985) (quotingHansonv.Denckla,357 U.S. 235, 253 (1958)).

A court must establish that it has either general or specific jurisdiction over a defendant before it can proceed with an action against the defendant. General jurisdiction is personal jurisdiction exercised over a defendant when the cause of action is unrelated to the defendant's contacts, but the defendant has sufficient contacts with the forum. Specific jurisdiction arises out of, or is related to, the defendant's contacts with the forum.See Helicopteros Nacionales de Colombiav.Hall, 466 U.S. 408, 414 (1984).

General jurisdiction has been found where the defendant was engaging in “continuous and systematic [though unrelated to the cause of action] business.”Perkinsv.Benguet Consolidated Mining Co., 342 U.S. 437, 438 (1952). To assert specific jurisdiction, a court is required to find that the defendant purposefully directed activities at residents in the forum, the claim arose out of those activities, and the assertion of personal jurisdiction is fair and reasonable.See Burger King,471 U.S. at 471-76.

Courts are cautious in exercise of jurisdiction over foreign defendants.See Asahi Metal Industry Co.v.Superior Court,480 U.S. 102, 114 (1987) (holding “unique burdens placed upon one who must defend oneself in a foreign legal system should have significant weight in assessing the reasonableness of stretching the long arm of personal jurisdiction over national borders.”). Considered critical to due process analysis is whether the foreseeability exhibited by defendant's conduct and its connections with the forum State demonstrate that the defendant would reasonably anticipate being brought into the forum court.See World-Wide Volkswagen Corp.v.Woodson,444 U.S. 286, 297-298 (1980).

With respect to Internet-related cases, the law of personal jurisdiction is in flux. The traditional minimum contacts approach has been used to determine whether a court has jurisdiction over a non-resident defendant in Internet-related intellectual property disputes. In such cases, the courts have looked to a variety of factors, including but not limited to the level of interactivity of the Web site; whether the tortious act was committed in state or out-of-state with impact in the state; the number of hits on the Web site; or the foreseeability of use by forum residents.See, e.g., Cybersell, Inc.v.Cybersell, Inc.,130 F.3d 414 (9th Cir. 1997);Zippo Mfg. Co.v.Zippo Dot Com,952 F. Supp. 1119 (W.D. Pa. 1997);Eskofot A/Sv.E.I. Du Pont De Nemours Co.,872 F. Supp. 81 (S.D.N.Y. 1995).

Federal district courts have jurisdiction over civil actions involving patents, trademarks and copyrights pursuant to 28 U.S.C. 1338(a), which provides: “The district courts shall have original jurisdiction of any civil action arising under any Act of Congress relating to patents, * * * copyrights and trademarks. Such jurisdiction shall be exclusive of the courts of the states in patent * * * and copyright cases.”

As mentioned above, federal courts have exclusive jurisdiction over all suits “arising under any Act of Congress relating to patents.” This includes all patent validity and infringement actions. Jurisdiction under this section extends “only to those cases in which a well-pleaded complaint establishes either that federal patent law creates the cause of action or that the plaintiff's right to relief necessarily depends on resolution of a substantial question of federal patent law.”Christiansonv.Colt Industries Operating Corp.,486 U.S. 800, 809 (1988).

Actions involving trademark infringement under the Lanham Act can be heard in either state or federal courts in the United States. However, most trademark actions arising out of the Lanham Act take place in federal court. Federal district courts have subject matter jurisdiction over all actions arising under the Lanham Act pursuant to § 39 of that Act, 15 U.S.C. 1121, as well as 28 U.S.C. 1338(a).

Section 14 of the Lanham Act creates an administrative proceeding within the USPTO where a party can petition to cancel a registered trademark. 15 U.S.C. 1064. Federal courts have concurrent jurisdiction with the USPTO to hear proceedings to cancel a mark, so long as the challenge arises from an existing trademark-related proceeding, as a result of § 37 of the Lanham Act. 15 U.S.C. 1119. Section 37 provides that a court may order the cancellation of a trademark registration “[i]n any action involving a registered trademark.” This section, however, does not create an independent ground for exercising jurisdiction over an action—the court must have subject matter jurisdiction based on another ground before considering cancellation of a registered trademark.See5 J. Thomas McCarthy,McCarthy on Trademarks and Unfair Competition,§ 30:110, pp. 30-186-88 (4th ed. 2000).

Federal courts have exclusive jurisdiction over actions based on the Copyright Act, including copyright infringement proceedings. 28 U.S.C. 1338(a).

The USPTO is interested in assessing support for or opposition to the effort to negotiate a convention on jurisdiction and enforcement of judgments and in obtaining comments on the proposed convention as it relates to intellectual property. Interested members of the public are invited to present written comments on any issues they believe to be relevant to protection of intellectual property or any aspect of the proposed convention as it relates to intellectual property. Comments also are welcome on the following specific issues:

1. What are your experiences in having judgments involving intellectual property from one jurisdiction recognized in a foreign court?

2. Have you had different experiences in having those judgments recognized in U.S. courts?

3. Are uniform rules for international enforcement of judgments desirable?

4. Do you support or oppose the United States becoming party to a jurisdiction/enforcement of judgments convention?

5. What would be the benefits or drawbacks of the United States becoming a party to the proposed Hague convention?

6. Would the elimination of tag or general “doing business” jurisdiction have any impact on intellectual property owners' ability to protect their rights either domestically or internationally?

7. What other changes to U.S. law would be needed to implement the proposed convention? Please identify any drawbacks and/or advantages to such changes.

8. What effect, if any, could this Convention have on other international intellectual property obligations, including, but not limited to, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Paris Convention, and the Berne Convention?

9. What effect, if any, could this Convention have on the enforcement of intellectual property with respect to the Internet?

10. Would application of Article 10 change existing jurisdictional principles as applied to intellectual property infringement actions? If yes, please describe any changes in detail and provide any relevant legal authority.

11. Would the limitation of worldwide damages in Article 10(4) have any significant impact in cases involving worldwide infringement of trademark or other intellectual property rights?

12. With respect to Article 12(4), under what circumstances would application of this subsection change existing jurisdictional principles, with and without the bracketed language included? Please describe any changes in detail and provide any relevant legal authority.

13. What effect, if any, would Article 12(4) have on trademark owners seeking to litigate rights related to registered versus common law marks?

14. Is exclusive jurisdiction needed for infringement and/or validity actions involving patents, trademarks, and/or copyrights?

15. What changes, if any, should be made to the proposed Convention? Please describe any changes in detail and provide any relevant legal authorities that support such suggestions.

16. Please identify any other potential concerns or advantages raised by the proposed convention.

In your response, please include the following: (1) clearly identify the matter being addressed; (2) provide examples, where appropriate, of the matter being addressed; (3) identify any relevant legal authorities applicable to the matter being addressed; and (4) provide suggestions regarding how the matter should be addressed by the United States.

The import restraint limits for textile products, produced or manufactured in Bahrain and exported during the period January 1, 2001 through December 31, 2001 are based on limits notified to the Textiles Monitoring Body pursuant to the Uruguay Round Agreement on Textiles and Clothing (ATC).

In the letter published below, the Chairman of CITA directs the Commissioner of Customs to establish the limits for the 2001 period.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (seeFederal Registernotice 64 FR 71982, published on December 22, 1999). Information regarding the 2001 CORRELATION will be published in theFederal Registerat a later date.

Sincerely,

The current limits for certain categories are being adjusted, variously, for swing, carryover, carryforward, carryforward used and special shift.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (seeFederal Registernotice 64 FR 71982, published on December 22, 1999). Also see 64 FR 68334, published on December 7, 1999.

The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception of the rulemaking provisions of 5 U.S.C. 553(a)(1).

Sincerely,

The current limit for Category 435 is being increased for carryforward.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (seeFederal Registernotice 64 FR 71982, published on December 22, 1999). Also see 64 FR 71116, published on December 20, 1999.

The current limits for certain categories are being adjusted, variously for carryforward used, swing, carryover and carryforward.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (seeFederal Registernotice 64 FR 71982, published on December 22, 1999). Also see 64 FR 68336, published on December 7, 1999.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,e.g.new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review:Extension.

Title:National Early Intervention Longitudinal Study (NEILS).

Frequency:Semi-Annually; Annually; Biennially.

Affected Public:Individuals or household; Not-for-profit institutions; State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

Responses:6,689;

Burden Hours:5,072.

Abstract:NEILS will provide the first national picture of experiences and outcomes for infants and toddlers served in early intervention (EI) under Part C of Individuals with Disabilities Education Act (IDEA) and their families. Data are collected from families, service records, and service providers. Findings will inform special education policy and practice regarding early intervention for young children with disabilities and their families. The study will support Government Performance and Results Act (GPRA) measurement and IDEA reauthorization with data from parents, service providers and teachers of children who received early intervention services.

Requests for copies of the proposed information collection request may be accessed fromhttp://edicsweb.ed.gov,or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW, Room 4050, Regional Office Building 3, Washington, D.C. 20202-4651. Requests may also be electronically mailed to the internet address OCIO_IMG_Issues@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at (202) 708-6287 or via her internet address Sheila_Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,e.g.new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review:New.

Title:New American High Schools Study—Phase I Activities.

Frequency:Annually.

Affected Public:Individuals or households.

Reporting and Recordkeeping Hour Burden:

Responses:32.

Burden Hours:144.

Abstract:The New American High Schools (NAHS) Study is a longitudinal research project. The overall goal of this effort is to document the practices and outcomes of a group of high schools engaged in whole-school improvement efforts in order to inform both policy debate and improve secondary education.

Requests for copies of the proposed information collection request may be accessed fromhttp://edicsweb.ed.gov,or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW, Room 4050, Regional Office Building 3, Washington, D.C. 20202-4651. Requests may also be electronically mailed to the internet address OCIO_IMG_Issues@ed.gov or faxed to 202-708-9346. Please specifythe complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at (202) 708-6287 or via her internet address Sheila_Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

The following proposed collection of information has been sent to OMB for clearance:

Collection Title:U.S. Department of Energy/Combined Heat and Power Registry

Type of Review:New collection.

OMB Number:None.

Type of Respondents:Individuals, Businesses, State and Local Governments.

Estimated Number of Respondents:1,000.

Estimated Total Burden Hours:500.

Frequency of Response:One time only.

DOE plans to publicize widely the existence of the registry through it's Regional Support Offices, the CHP website, meetings, conferences and the like, and through its relationship with CHP organizations. Due to the recent high level of interest in CHP, DOE expects that many CHP installers, individuals, utilities, governments, and businesses will wish to register their CHP systems in order to gain recognition on the CHP webpage and also be potentially eligible for an award. Registration would take place electronically (a paper form would be available upon request) by responding to a series of very brief questions. If a system met the established criteria, a CHP certificate would be sent to the facility. Registration would take place one time only. DOE plans to aggregate the data and generate reports detailing the geographic distribution of systems and among other things, the sizes and types of systems. This data collection will assist DOE in its management of and planning for the continued success of the CHP initiative.

Purpose of the Board:The purpose of the Board is to make recommendations to DOE and its regulators in the areas of environmental restoration, waste management, and related activities.

Public Participation:The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Ken Korkia at the address or telephone number listed above. Requests must be received at least five days prior to the meeting and reasonable provisions will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Each individual wishing to make public comment will be provided a maximum of five minutes to present their comments.

Minutes:The minutes of this meeting will be available for public review and copying at the Public Reading Room located at the Office of the Rocky FlatsCitizens Advisory Board, 9035 North Wadsworth Parkway, Suite 2250, Westminister, CO 80021; telephone (303)420-7855. Hours of operations for the Public Reading Room are 9 a.m. to 4 p.m., Monday-Friday, except Federal holidays. Minutes will also be made available by writing or calling Deb Thompson at the address or telephone number listed above.

In recent years, State, territory, and tribal water quality assessments have identified nonpoint source (NPS) pollution as the most significant cause of degradation in surveyed waters nationwide. In 1987, Congress enacted section 319 of the Clean Water Act to establish a national program to control nonpoint sources of water pollution. Under Section 319, States, territories, and tribes address NPS pollution by assessing the NPS pollution problems within the state, territory, or tribal lands, identifying the sources of pollution, and implementing management programs to control the NPS pollution. Section 319 also authorizes EPA to award grants to States and tribes to assist them in implementing management programs which have been approved by EPA. Program implementation includes non-regulatory and regulatory programs, technical assistance, financial assistance, education, training, technology transfer, and demonstration projects. In fiscal year 2000, Congress appropriated and EPA awarded $200 million dollars for nonpoint source management program grants. EPA has awarded a total of $1 billion under Section 319 to States, Territories, and Indian tribes since 1990.

In 1993, under the authority of section 6217(g) of the Coastal Zone Act Reauthorization Amendments, EPA issuedGuidance Specifying Management Measures for Sources of Nonpoint Pollution in Coastal Waters(EPA840-B-92-002). That guidance document details management measures appropriate for the control of five sources of nonpoint pollution in the coastal zone: agriculture, forestry, urban areas, marinas and recreational boating, and hydromodification. The document also includes management measures for wetlands, riparian areas, and vegetated treatment systems as they are important to the abatement of nonpoint source pollution in coastal waters. State and Territory Coastal Nonpoint Pollution Control Programs were required to adopt measures “in conformity” with the coastal management measures guidance.

The 1993 management measures guidance focused on conditions and examples of management measure implementation from the coastal zone. To date, technical guidance on the best available, economically achievable measures for controlling nonpoint sources with a national scope has not been released. The draft national management measures guidance is intended to address this gap. While the practices detailed in the 1993 guidance generally apply to inland areas, EPA has recognized the utility of developing and publishing a technical guidance document that explicitly addresses nonpoint source pollution on a nationwide basis. Moreover, additional data and examples from inland regions are available to enrich the national guidance. In addition, significant changes have occurred in sectors of the agriculture industry since 1993. These changes have helped to prompt the revision and expansion of the agriculture chapter of the 1993 guidance.

The draft technical guidance continues to focus on the major sources of agricultural pollution identified in the 1993 coastal guidance by EPA in consultation with a number of other federal agencies and other leading national experts, including several experts from State land grant universities. Specifically, the guidance identifies management measures for the following:

1. Nutrients;

2. Pesticides;

3. Erosion and sediment;

4. Animal feeding operations;

5. Grazing; and

6. Irrigation water.

The draft national management measures guidance is based in large part on the 1993 coastal guidance. The 1993 coastal guidance was developed using a workgroup approach to draw upon technical expertise within other Federal agencies as well as State water quality and coastal zone management agencies.

The 1993 text has been expanded to include more background information on standard agricultural practices (e.g.,why farmers irrigate, history of pesticides) and to address emerging issues in agriculture (e.g.,precision farming). The draft guidance also incorporates examples and data from the inland regions of the United States (e.g.,grazing in Colorado) in addition to improving the coverage of unique coastal environments (e.g.,Hawaii). The document also updates information on technologies and the costs of management measures where new data has become available since the publication of the coastal guidance.

Only one of the management measures from the 1993 document has been altered in substance: the management measure for animal feeding operations. The coastal guidance contained a management measure whose implementation involved storing facility wastewater and runoff from confined animal facilities for all storms up to and including a 25-year, 24-hour storm and the management of stored runoff and accumulated solids through an appropriate waste utilization system for operations of more than 300 animal units. The management measure in the 1993 coastal guidance does not involve the implementation of manure storage structures or areas, only the control of runoff from such areas. The draft guidance recommends implementation of adequate manure storage in addition to the management of runoff, diversion of clean water, application of manure in accordance with a nutrient management plan, and protection of land receiving wastes through the use of other management measures (i.e.,grazing, irrigation water, erosion control), as appropriate. Recent concern over the management of wastes from animal feeding operations, changes in standard practice within the livestock industry, the enactment and promulgation of many new State laws and regulations throughout the country, and the recent publication of the joint U.S. Department of Agriculture/U.S. Environmental Protection Agency Unified National Strategy for Animal Feeding Operations (March 1999) prompted the alterations to the management measure for animal feeding operations described above.

EPA is soliciting comments on the draft guidance on management measures to control agricultural sources of nonpoint pollution. The Agency is soliciting additional information and supporting data on the measures specified in this guidance and on additional measures that may be as effective or more effective in controlling nonpoint source pollution from agriculture.

This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

1.Electronically. You may obtain copies of this document and certain other available documents from the EPA Internet Home Page at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to theFederal Registerlistings at http://www.epa.gov/fedrgstr/.

2.In person. The Agency has established an official record for this action under docket control number OPPTS-51953. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, isavailable for inspection in the TSCA NonConfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the center is (202) 260-7099.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-51953 and the specific PMN number in the subject line on the first page of your response.

1.By mail. Submit your comments to: Document Control OffiCe (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2.In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.

3.Electronically. You may submit your comments electronically by e-mail to: “oppt.ncic@epa.gov,” or mail your computer disk to the address identified in this unit. Do not submit any information electronically that you consider to be CBI. Electronic Comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-51953 and the specific PMN number. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed underFOR FURTHER INFORMATION CONTACT.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, andFederal Registercitation.

Section 5 of TSCA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a notice of receipt of a PMN or an application for a TME and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from August 28, 2000 to September 8, 2000, consists of the PMNs and TMEs, both pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

This status report identifies the PMNs and TMEs, both pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. If you are interested in information that is not included in the following tables, you may contact EPA as described in Unit II. to access additional non-CBI information that may be available.

In table I, EPA provides the following information (to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: the EPA case number assigned to the PMN; the date the PMN was received by EPA; the projected end date for EPA's review of the PMN; the submitting manufacturer; the potential uses identified by the manufacturer in the PMN; and the chemical identity.

OMB Control Number:3060-0816.

Title:Local Competition and Broadband Reporting, CC Docket No. 99-301.

Form Number:FCC Report 477.

Type of Review:Extension of a currently approved collection.

Respondents:Business or other for-profit entities.

Number of Respondents:255.

Estimate Time Per Response:58.67 hours (avg.).

Frequency of Response:Semi-annual reporting requirement.

Total Annual Burden:29,924 hours.

Total Annual Costs:None.

Needs and Uses:The FCC Form 477 seeks to gather information on the development of local competition and deployment of broadband service also known as advanced telecommunications services. The data are necessary to evaluate the status of developing competition in local exchange telecommunications markets and to evaluate the status of broadband deployment. The Commission staff uses the information to advise the Commission about the efficacy of the FCC rules and policies adopted to implement the Telecommunications Act of 1996.

OMB Control Number:3060-XXXX.

Title:Notification of Emergency Alert System Status.

Form Number:N/A.

Type of Review:New collection.

Respondents:Business or other for-profit entities; Not-for-profit institutions; and State, local, or tribal government.

Number of Respondents:125.

Estimate Time Per Response:30 minutes.

Frequency of Response:On occasion reporting requirement.

Total Annual Burden:62 hours.

Total Annual Costs:None.

Needs and Uses:Due to the state's size, remoteness, and isolation, it is difficult for the resident agent of the FCC's Alaska office to make on-the-scene inspections to insure that the FM translators are in compliance with the Emergency Alert System (EAS) rules adopted on January 1, 1997. The agent is, therefore, developing a survey to determine whether the FM translators are either rebroadcasting local programming in their entirety, including the EAS warnings, or, if not, then whether the FM translator station has EAS equipment installed and working properly. FM translator stations that are not in compliance could present a safety-of-life issue to the listening public.

In the May 1997Universal Service Order,62 FR 32862 (June 17, 1997), the Commission, acting on the recommendation of the Federal-State Joint Board on Universal Service (the Joint Board), encouraged the Joint Board to establish a Rural Task Force to “provide valuable assistance in identifying the issues unique to rural carriers and analyzing the appropriateness of proxy cost models for rural carriers.” On September 17, 1997, the Joint Board announced the creation of the Rural Task Force and directed it to present a report to the Joint Board making specific recommendations on the establishment of a forward-looking economic cost mechanism for rural telephone companies. The Joint Board will consider this report in formulating a recommendation to the Commission for universal service reform for rural carriers.

On September 29, 2000, the Rural Task Force submitted the Rural Task Force Recommendation To The Federal-State Joint Board On Universal Service. This recommendation, as well as supporting materials, are available on the Joint Board's Web page athttp://www.fcc.gov/ccb/universal service/joint.htmland the Rural Task Force's Web site athttp://www.wutc.wa.gov/rtf.Consistent with the procedures outlined below, the Joint Board seeks comment on the recommendation.

Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments on or before November 3, 2000, and reply comments on or before November 30, 2000. All filings should referenceFederal-State Joint Board On Universal Service,CC Docket No. 96-45,Comments on the Rural Task Force Recommendationand should include the FCC number shown on this Public Notice. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies.See Electronic Filing of Documents in Rulemaking Proceedings,63 FR 24121 (1998). Comments filed through the ECFS can be sent as an electronic file via the Internet to http://www.fcc.gov/e-file/ecfs.html. Generally, only one copy of an electronic submission must be filed. If multiple docket or rulemaking numbers appear in the caption of this proceeding, however, commenters must transmit one electronic copy of the comments to each docket or rulemaking number referenced in the caption. In completing the transmittal screen, commenters should include their full name, Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit electronic comments by Internet e-mail. To receive filing instructions for e-mail comments, commenters should send an e-mail to ecfs@fcc.gov, and should include the following words in the body of the message, “get form your e-mail address.” A sample form and directions will be sent in reply. Parties who choose to file by paper must file anoriginal and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, commenters must submit two additional copies for each additional docket or rulemaking number. All filings must be sent to the Commission's Secretary, Magalie Roman Salas, Office of the Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.

Parties should also send three paper copies of their filing to Sheryl Todd, Accounting Policy Division, Common Carrier Bureau, Federal Communications Commission, 445 Twelfth Street SW., Room 5-B540, Washington, DC 20554 and to the individuals listed on the attached service list. In addition, commenters must send diskette copies to the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20037.

This is a summary of a public notice released October 6, 2000 (“Auction No. 36 Public Notice”). The complete text of the “Auction No. 36 Public Notice,” including all attachments, is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW, Washington, DC. It may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (ITS, Inc.) 1231 20th Street, NW, Washington, DC 20036, (202) 857-3800. It is also available on the Commission's website athttp://www.fcc.gov/wtb/auctions.List of Attachments available at the FCC:

1. The Federal Communications Commission (“FCC”) has received 40FCC Form 175 applications to participate in Auction No. 36 scheduled to begin on Wednesday, November 1, 2000, for 2,800 licenses in the 800 MHz Band. The applications have been reviewed for completeness and compliance with the Commission's rules, and have been classified into the following categories:

Accepted for Filing:20 Applications.

Incomplete:19 Applications.

Rejected:1 Application.

Accepted:Applications accepted for filing are listed alphabetically in Attachment A of theAuction No. 36 Public Notice.These applicants will become qualified bidders upon receipt of the required upfront payment due by 6:00 p.m. ET on Monday, October 16, 2000.See47 CFR 1.2106. With respect to the FCC Form 175 applications, these applicants need take no further action except as may be necessary to maintain the accuracy of their applications.See47 CFR 1.65. Also, applicants are advised that Attachment A includes FCC account numbers that were automatically created by the FCC software system for each applicant, and which are applicable for bidding only.

Incomplete:Applications found to be incomplete are listed alphabetically in Attachment B of theAuction No. 36 Public Notice.Applicants whose FCC Form 175 applications have been deemed incomplete will receive overnight correspondence indicating what information is required to make the applications acceptable for filing. These applicants may become qualified bidders only if they: (i) Resubmit their applications by 6:00 p.m. ET on Monday, October 16, 2000, to correct the minor deficiencies indicated; and (ii) make the required upfront payments by 6:00 p.m. ET on Monday, October 16, 2000. Applicants must also maintain the accuracy of their FCC Form 175 applications as required by the Commission's rules. In addition, applicants are advised that Attachment B includes FCC account numbers that were automatically created by the FCC software system for each applicant. These account numbers are applicable for bidding purposes only, should the applicant become eligible to participate in Auction No. 36.

2. The filing window for resubmitting FCC Form 175 applications is now open. Corrected applications must be filed no later than 6:00 p.m. ET on Monday, October 16, 2000. This will be the only opportunity to cure FCC Form 175 defects; late resubmissions will not be accepted. In addition, if an application remains incomplete or otherwise deficient after the resubmission deadline has passed, the application will be rejected.

Rejected:The application(s) classified as rejected are listed in Attachment C. Applicants whose applications have been rejected are disqualified from participation in Auction No. 36.

3. Upfront payments and accompanying FCC Remittance Advice (FCC Form 159) for Auction No. 36 are due and must be received at Mellon Bank, Pittsburgh, Pennsylvania, no later than 6:00 p.m. ET on Monday, October 16, 2000. Payments must be made by wire transfer and applicants must include their Taxpayer Identification Numbers (TIN). No other payment method is acceptable for this auction. Applicants are reminded to use their TIN and not their FCC Account Numbers on the FCC Remittance Advice (FCC Form 159).

4. Applicants that have filed applications deemed to be incomplete, as noted in this public notice, must submit timely and sufficient upfront payments before the Commission will review their resubmitted applications. If such an application remains incomplete following its resubmission, the application will be dismissed. If the applicant has provided its Taxpayer Identification Number (TIN) and wire transfer instructions, the upfront payment will be refunded automatically.

5.Qualified Bidders:Approximately one week after upfront payments have been received, resubmitted FCC Form 175 applications have been processed and reviewed, and the correlation of payments and applications have been made, a public notice listing all applicants qualified to bid in the auction will be released. The same public notice will also include instructions on how to access the auction tracking tool software, a bidding schedule for the Mock auction, and the bidding schedule for the first day of the auction.

6.Prohibition of Collusion:Bidders are reminded that § 1.2105(c) of the Commission's Rules prohibits applicants for the same geographic license area from communicating with each other during the auction about bids, bidding strategies, or settlements unless they have identified each other as parties with whom they have entered into agreements under § 1.2105(a)(2)(viii). For Auction No. 36, this prohibition became effective at the filing deadline of short-form applications on Friday, September 29, 2000, and will end on the post-auction down payment due date. The post-auction down payment due date will be announced in a future public notice. If parties had agreed in principle on all material terms, those parties must have been identified on the short-form application under § 1.2105(c), even if the agreement had not been reduced to writing. If parties had not agreed in principle by the filing deadline, an applicant should not have included the names of those parties on its application, and must not have continued negotiations with other applicants for licenses in the same geographic area. For further details regarding the prohibition against collusion, refer to theAuction No. 36 Public Notice.

7. In addition, applicants are reminded that they are subject to the antitrust laws, which are designed to prevent anti-competitive behavior in the marketplace. Winning bidders will be required to disclose in their long-form applications the specific terms, conditions and parties involved in all bidding consortia, joint ventures, partnerships, and other arrangements entered into relating to the competitive bidding process. Bidders found to have violated the anti-collusion rule may be subject to sanctions.

8.Ex Parte Rule:Applicants should also be aware that the Commission has generally exempted auction proceedings from the strict requirements of theex parterule found in 1.2106 of the Commission's rules.

9.Mock Auction:All applicants found to be qualified bidders are eligible to participate in a mock electronic auction on Monday, October 30, 2000. In theQualified Bidders Public Notice,the Bureau will announce when software for the mock auction will be posted on the World Wide Web.

10.Remote Bidding Software:Applicants are reminded that qualified bidders are eligible to bid either electronically or telephonically. To bid electronically, applicants should complete the software order form included in theAuction No. 36 Public Notice,or contact the Auctions Hotline at (717) 338-2888. To ensure timely delivery of remote bidding software before the auction begins, the Commission requests receipt of software orders by 6:00 p.m. ET on Tuesday, October 17, 2000. The minimum hardware and software specifications required for the FCC remote bidding system are listed:

To download Netscape Communicator 4.73 free of charge, access the Netscape download site at http://home.netscape.com/download/.

11.Long-Form Applications:All applicants should be aware that at the long-form application stage, they will be subject to the more extensive reporting requirements contained in the Commission's Part 1 ownership disclosure rule.

12.Bidder Alerts:All applicants must certify on their FCC Form 175 applications under penalty of perjury that they are legally, technically, financially and otherwise qualified to hold a license, and not in default on any payment for Commission licenses (including down payments) or delinquent on any non-tax debt owed to any Federal agency. Prospective bidders are reminded that submission of a false certification to the Commission is a serious matter that may result in severe penalties, including monetary forfeitures, license revocations, exclusion from participation in future auctions, and/or criminal prosecution.

13. Information about deceptive telemarketing investment schemes is available from the FTC at (202) 326-2222 and from the SEC at (202) 942-7040. Complaints about specific deceptive telemarketing investment schemes should be directed to the FTC, the SEC, or the National Fraud Information Center at (800) 876-7060. Consumers who have concerns about specific proposals may also call the FCC Consumer Center at (888) CALL-FCC ((888) 225-5322).

You may call 202-452-3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at http://www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting.

Over the next five years, brand-name drugs with combined U.S. sales approaching $20 billion will go off patent.1 Manufacturers seeking to protect the sales of branded drug products may have an incentive and ability to enter into agreements with would-be generic competitors that would slow or thwart the entry of competing generic drug products approved by the Food and Drug Administration pursuant to its authority under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act).

The FTC invites comment on: (1) Whether the proposed collections of information are necessary for the proper performance of the functions of the FTC, including whether the information will have practical utility; (2) the accuracy of the FTC's estimate of the burden of the proposed collections of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of collecting the information on those who are to respond, including through the use of collection techniques or other form of information technology,e.g., permitting electronic submissions of responses. The FTC will submit the proposed information collection requirements to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

The FTC proposes to send information requests to approximately 30 innovator drug companies (i.e., brand-name drug manufacturers) and 60 generic drug companies to examine their use of agreements and other strategies that may affect generic drug competition. The companies to which the information requests would be sent include name-brand pharmaceutical drug companies that have received notice of the filing of an Abbreviated New Drug Application (ANDA), as defined by 21 U.S.C. 355(j), and generic drug companies that have filed such ANDAs since January 1, 1991. In addition to routine questions about the name, address, and incorporation date of the responding company and its subsidiaries, and the name, business address, and official capacity of the official supervising the company's response, the FTC will ask innovator drug companies to provide answers to the following four questions:

1. Submit all agreements between the company and any person2 (including corporations or other business entities acquired since the agreement(s) was (were) executed) executed after January 1, 1991, relating to3 an ANDA, involving any Drug Product.4 Examples of such agreements include, but are not limited to: (a) Patent litigation settlements (full or partial) between the company and persons that have filed an ANDA involving any Drug Product; (b) agreements related to the filing (or non-filing) of an ANDA by any applicant (or potential applicant) involving any Drug Product; (c) licensing agreements between the company and persons that have filed an ANDA involving any Drug Product; and (d) agreements related to any acquisition, divestiture, joint venture, alliance, license or merger by the company of any business involving the research, development, manufacture or sale of any Drug Product that is the subject of an ANDA. The company is not required to submit purchase orders for base active materials, equipment and facility contracts, and employment contracts. For any such agreement submitted, also submit all studies, surveys, analyses and reports which were prepared by or for any officer(s) or director(s) of the company (or, in the case of unincorporated entities, individuals exercising similar functions) that evaluate or analyze the reasons for making such agreement (or any of the provisions in such agreement), and indicate (if not contained in the document itself) the date of preparation, and the name and title of each individual who prepared each such document.

2. Identify all patents that the company has filed in the Orange Book and the date of listing (regardless of whether they are currently listed in the Orange Book) relating to any Drug Product for which the company has been notified of the filing of an ANDA by another person. Also indicate if the patent(s) was (were) filed after the company received approval of the New Drug Application, as defined under 21 U.S.C. 355(b)et seq., for the Drug Product. Also submit a copy of each such patent identified and identify whether the patent is owned by, assigned to, or licensed to the company.

3. Identify and list all lawsuits since January 1, 1991 (including the court, date filed, docket number, parties, current or final status (including dates), current or final docket sheet, and any reporter cites) to which the company is or was a party that involve an ANDA paragraph IV certification related to any Drug Product. Submit the complaint, the answer, any motion(s) for summary judgment, and any court orders for each such lawsuit.

4. For each Drug Product for which the company has been notified that an ANDA containing a paragraph IV certification had been filed with the FDA, state the company's sales,5 in units and dollars, by dosage for each calendar year since, and including, the year the company was notified of the filing of such ANDA.

In addition to routine questions about the name, address, and incorporation date of the responding company and its subsidiaries, and the name, business address, and official capacity of the official supervising the company's response, the FTC will ask generic drug companies to provide answers to the following five questions:

1. Submit all agreements between the company and any other person6 (including corporations or other business entities acquired since the agreement(s) was (were) executed) executed after January 1, 1991, relating to7 any ANDA involving any Drug Product.8 Examples of such agreementsinclude, but are not limited to: (a) Patent litigation settlements (either full or partial) between the company and any Innovator Company;9 (b) agreements between the company and any other person related to the filing (or non-filing) of an ANDA by the company involving any Drug Product; (c) licensing agreements entered into with any Innovator Company; and (d) agreements related to any acquisition, divestiture, joint venture, alliance, license or merger by the company of any business involving the research, development, manufacture or sale of any Drug Product that is the subject of an ANDA. The company is not required to submit purchase orders for base active materials, equipment and facility contracts, and employment contracts. For any such agreement submitted, also submit all studies, surveys, analyses and reports which were prepared by or for any officer(s) or director(s) (or, in the case of unincorporated entities, individuals exercising similar functions) that evaluate or analyze the reasons for making such agreement (or any of the provisions in such agreement), and indicate (if not contained in the document itself) the date of preparation, and the name and title of each individual who prepared each such document.

2. Identify and list all lawsuits since January 1, 1991 (including the court, date filed, docket number, parties, current or final status (including dates), current or final docket sheet, and any reporter cites) to which the company is or was a party involving an ANDA paragraph IV certification. In those cases in which the company is not the sole defendant, describe how litigation expenses are or have been distributed among the parties.

3. Identify when the company began first commercial marketing of a generic version of any Drug Product approved by the FDA since January 1, 1991 in those instances in which the Innovator Company brought an action for infringement of a patent against the company or any other ANDA applicant (or, if applicable, indicate that no such commercial marketing has occurred). Identify when the company received tentative and final approvals from the Food and Drug Administration (FDA) for such Drug Product.

4. Identify each instance in which the company has asserted before a court or before the FDA that a patent was improperly or untimely listed as defined in 21 U.S.C. 355(b) or (c). For each such assertion, submit the pleading(s) in which such assertion was made and any responsive pleading(s).

5. For each Drug Product for which the company has filed an ANDA containing a paragraph IV certification, state the company's sales10 (if any), in units and dollars, by dosage for each calendar year since, and including, the year the company received approval of such ANDA.

The FTC will obtain the information sought by interrogatories and document requests under section 6(b) of the FTC Act, 15 U.S.C. 46(b). The documents and information obtained through these orders will help the FTC determine whether agreements or other strategies are being used to delay generic drug competition and thus may merit law enforcement action, and to evaluate the effectiveness of the generic drug provisions of the Hatch-Waxman Act. It should be noted that subsequent to this notice any destruction, removal, mutilation, alteration, or falsification of documentary evidence that may be responsive to this information collection within the possession or control of a person, partnership or corporation subject to the FTC Act is subject to criminal prosecution. 15 U.S.C. 50;see also18 U.S.C. § 1505.

The FTC will ask members of the pharmaceutical industry to answer several written questions and to produce documents related to the answers provided. Because the responses will necessarily vary depending upon the extent to which drug companies have entered into such agreements, listed patents in the Orange Book, engaged in litigation related to ANDAs containing a paragraph IV certification, and commercially marketed particular generic drug products, the FTC has provided a range of estimated response times from 90 hours to 400 hours. The total estimated burden of answering the questions and producing documents per respondent is based on the following:

Organize document and information retrieval:15-50 hours.

Identify requested information:15-150 hours.

Retrieve responsive information:20-80 hours.

Copy requested information:20-40 hours.

Prepare response:20-80 hours.

Thus, the cumulative hours burden to produce documents and prepare the response sought will be between 8,100 hours (90 hours × 90 companies) and 36,000 hours (400 hours × 90 companies).

It is not possible to calculate with precision the labor costs associated with answering the questions and producing the documents requested, as responses will entail participation by management and/or support staff at various compensation levels among many different companies. Individuals among some or all of those labor categories may be involved in the information collection process. Nonetheless, the FTC has assumed that mid-management personnel will handle most of the tasks involved in gathering and producing the responsive information, and has applied an average hourly wage of $150/hour for their labor. The FTC also has applied an average hourly wage of $10 for the labor of clerical employees who will copy the responsive materials. Thus, the labor costs per company should range between $10,700 [(70 hours × $150/hour) + (20 hours × $10/hour)] and $53,000 [(350 hours × $150/hour) + (50 hours × $10/hour)].

The FTC estimates that the capital or other non-labor costs associated with the information requests will be minimal. Although the information requests may require that respondent retain copies of the information provided to the Commission, industry members should already have in place the means to store information of the volume requested. In addition, respondents may have to purchase office supplies such as file folders, computer diskettes, photocopier toner, or paper in order to comply with the Commission's requests. The FTC estimates that each respondent will spend $500 for such costs regarding the information request, for a total additional non-labor cost burden of $45,000 ($500 × 90 companies).

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of the Commisison's Rules of Practice (16 CFR 2.34), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for October 5, 2000), on the World Wide Web, at “http://www.ftc.gov/os/2000/09/index.htm.” A paper copy can be obtained from the FTC Public Reference Room, Room H-130, 600 Pennsylvania Avenue NW., Washington, DC 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Comments should be directed to: FTC/Office of the Secretary, Room 159, 600 Pennsylvania. Ave., NW., Washington, DC 20580. Two paper copies of each comment should be filed, and should be accompanied, if possible by a 31/2-inch diskette containing an electronic copy of the comment. Such comments or views will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with section 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii)).

The Federal Trade Commission has accepted an agreement to a proposed consent order from Weider Nutrition International, Inc. (hereinafter “Weider”).

The proposed consent order has been placed on the public record for thirty (30) days for the reception of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and any comments received and will decide whether it should withdraw from the agreement and take other appropriate action or make final the agreement's proposed order.

This matter involves advertisements for a dietary supplement called PhenCal or PhenCal 106. Advertisements claimed that PhenCal and PhenCal 106 have been proven to cause weight loss and to prevent the regaining of lost weight. These advertisements appeared in major newspapers such as the New York Times, the Washington Post, and USA Today.

The proposed complaint alleges that Weider could not substantiate claims that PhenCal and PhenCal 106: (1) Cause significant weight loss; (2) significantly increase a person's ability to maintain a reduced caloric diet and exercise program; (3) significantly reduce food cravings and eating binges; (4) prevent the regaining of lost weight; (5) are as effective as the prescription weight loss treatment commonly known as “Phen-Fen”; and (6) are safe when used to promote or maintain weight loss. The complaint also alleges that Weider made false representations that claims (1), (3), (4), (5), and (6) above, had been scientifically proven.

The proposed consent order contains provisions designed to prevent the respondent from engaging in similar acts and practices in the future.

Part I of the proposed order requires respondent, when advertising any food, drug, dietary supplement or program, to possess competent and reliable scientific evidence before making claims (1) through (6) above.

Part II of the proposed order requires respondent, when advertising any food, drug, dietary supplement, or program, to possess competent and reliable scientific evidence before making claims relating to—

A. The safety of such product or program;

B. The effect of such product or program on any disease; or

C. The comparative or superior health benefit of such product or program with respect to any other product or program.

Part III prohibits respondent from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study or research in an advertisement for any food, drug, dietary supplement or program.

Part IV allows the respondent to make representations for any drug that are permitted in labeling for that drug under any tentative final or final Food and Drug Administration (“FDA”) standard or under any new drug application approved by the FDA.

Part V allows the respondent to make representations for any product that are specifically permitted in labeling for that product by regulations issued by the FDA under the Nutrition Labeling and Education Act of 1990.

Part VI requires respondent to pay $400,000 to the Commission. These funds will be used for consumer redress or, if that is impracticable, the funds will be paid to the United States Treasury.

Part VII requires respondent to retain, and make available to the Commission, upon request, all advertisements and promotional materials containing any representation covered by the order, as well as any materials that it relied upon in disseminating the representation and any materials that contradict, qualify, or call into question the representation.

The remainder of the proposed order contains standard requirements that the respondent distribute the order to relevant personnel, that respondent notify the Commission of any changes in corporate structure that might affect compliance with the order and that the respondent file one or more reports detailing its compliance with the order.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order, or to modify in any way its terms.

The President established the National Bioethics Advisory Commission (NBAC) on October 3, 1999 by Executive Order 12975 as amended. The mission of the NBAC is to advise and make recommendations to the National Science and Technology Council, its Chair, the President, and other entities on bioethical issues arising from the research on human biology and behavior, and from the applications of that research.

The meeting is open to the public with attendance limited by the availability of space on a first come, first serve basis. Members of the public who wish to present oral statements should contact Ms. Jody Crank by telephone, fax machine, or mail as shown below as soon as possible, at least 4 days before the meeting. The Chair will reserve time for presentations by persons requesting to speak and asks that oral statements be limited to five minutes. The order of persons wanting to make a statement will be assigned in the order in which requests are received. Individuals unable to make oral presentations can mail or fax their written comments to the NBAC staff office at least five business days prior to the meeting for distribution to the Commission and inclusion in the public record. The Commission also accepts general comments at its website at bioethics.gov. Persons needing special assistance, such as sign language interpretation or other special accommodations, should contact NBAC staff at the address or telephone number listed below as soon as possible.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

FDA regulations in part 123 (21 CFR part 123) mandate the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of seafood. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and became effective on December 18, 1997.

Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor's HACCP plan (e.g., the values for processing times, temperatures, acidity, etc. as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls.

Section 123.12 requires that importers of seafood products take affirmative steps and maintain records that verify that the fish and fishery products they offer for import into the United Stateswere processed in accordance with the HACCP and sanitation provisions set forth in part 123. These records are also to be made available for review by FDA as provided in § 123.12(c).

The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and the nature of the equipment or instruments required to monitor critical control points. The burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry.

The burden estimate in table 1 includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. For example, the current good manufacturing practices provisions in 21 CFR part 110 already require that all food processors ensure good sanitary practices and conditions, monitor the quality of incoming materials, monitor and control food temperatures to prevent bacterial growth, and perform certain corrective actions and verification procedures. Furthermore, the estimate does not include collections of information that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently the estimates in table 1 account only for new information collection and recording requirements attributable to part 123.

In theFederal Registerof July 21, 2000 (65 FR 45382), the agency requested comments on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows: